Specifications ensure drug substances/products meet acceptance criteria, forming a foundation for robust control strategies. Validated methods must be fit for purpose, with MODRs providing flexibility ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

(MENAFN- GlobeNewsWire - Nasdaq) This program opens opportunities in enhancing statistical skills for validation projects, focusing on variance, sample distributions, and process capability, which are ...

This course will provide you with the requisite scientific knowledge and understanding of analytical method lifecycle management, which includes the activities of validation, verification, transfer, ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Statistical Methods for Process Validation (Sept 24, 2025)" training has been added to ResearchAndMarkets.com's offering. In this program, we will ...